CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Vadadustat +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Japanese male or female participants aged ≥20 years
  • ✓On chronic maintenance hemodialysis for end-stage kidney disease
  • ✓Hemoglobin level <10.0 g/dL
Key exclusion· 4
  • ✕Anemia due to cause other than CKD, or active bleeding or recent blood loss
  • ✕Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
  • ✕Red blood cell transfusion within 4 weeks prior to or during screening
  • ✕Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03054350
NCT03054350Phase 2Completed
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Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Akebia Therapeutics·interventional·Posted Feb 15, 2017·Updated Apr 8, 2021

In Brief

A Phase 2 clinical trial evaluating Vadadustat and Placebo for Anemia and Dialysis Dependent Chronic Kidney Disease. Completed, enrolled 60 participants across 18 sites.

Detailed Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent Chronic Kidney Disease (DD-CKD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Dialysis Dependent Chronic Kidney Disease
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 15, 2017
Enrollment StartDec 1, 2016
Primary CompletionOct 24, 2017
Study CompletionJan 24, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.4 years ago

Interventions

Vadadustatdrug

Daily oral dose

Placebodrug

Daily oral dose